Actualizado el 01/06/2022
- Tech Transfer, scalability, validation, compliance, regulatory, manufacturing
- Finished Dosage Forms (FDF) & CMOs
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API Multinational Company
MST & Project Manager, ESO Owns technical stewardship of FDF products (E2E oversight of manufacturing process & technology, specifications, validation & continuous improvement), support regulatory with filing/maintenance questions, QA support with troubleshooting customer/supplier matters all in coordination with CDMO/CRO's and other company departments. Owns & leads technology transfers as part of network optimization/portfolio expansion plans and responsible for project team.
The main activities and responsibilities
- General: Represent the technology function in ESO with coordination across the company and 3rd parties. Build and maintain an adequate external network to deliver on customer commitments and long-term growth plans. Acts as SPoC & SME across the company on all product, process & technology related matters in compliance with industry regulatory/quality guidelines.
- Operational: accountable for ensuring the portfolio is maintained in a validated/compliant status across the product lifecycle. Develops portfolio risk assessment and implements annual continuous improvement plans for marketed portfolio. Technical coordination/support with CDMO/CRO & Centrient departments across product, process, specification & technology, related to Regulatory maintenance/new filings, Quality action points/troubleshooting and root-cause/CAPA of production issues.
- Tech transfer & network due- diligence: Project lead for assigned dossier/tech transfers across FDF manufacturing network. Accountable for delivering against business case mandate across the entire project scope (e.g. technical protocol development, AMT, engineering batches, scale-up/validation & dossier submission). Responsible for coordinating a cross-functional project team, their deliverables and reporting status through governance. Responsible for providing technical due-diligence support on portfolio/asset acquisitions and evaluation of new to network CRO/CDMO's.
- Shared responsibility in cross-functional Teams within ESO & FDF organization
- Give Technology support to own FDF Development Team and other disciplines, company-wide within the company
- General compliance
- Being responsible for budget/cost, timeline, and risk management of assigned technical projects
Perfil Buscado (H/M/D)
- At least 6 years of experience in Pharmaceutical Technology, preferably in Generics.
- Academic degree (MSc) in Technology, Pharmacy, Biochemistry or related field. Advanced degree preferred.
- Broad, multidisciplinary experience.
- Professional English level (company official language)
- Well-trained in all relevant Quality and SHE policies and procedures.
- Managerial and social knowledge and experience.
- Having extensive experience in pharmaceutical production (Test to Pilot to Full-scale).
- Having experience in analytical chemistry.
- Having extensive experience in collaborations with (international) third parties.
- Having experience in bringing generics to the Market.
- Customer and external focus.
- Drive for results.
- Improve, Innovate and Change.
- Engage People.
- Act Responsibly.
- Passion for success and driving results
- Improve, Innovate and Change
- Flexible, agile, proactive with a "never give up" type of mindset
- Customer and external focus
- Structured, Analytical, Creative
- Collaborating cross-functional, both internally and with 3rd parties, Engage People
- Multinational environment
- Fix contract
- Barcelona based but open for international home office
- Great salary package